Senior Manager; QA Compliance-Audits

Company: Contract Pharmacal Corp
Location: Hauppauge
Posted on: January 24, 2023

Job Description:

Senior Manager; QA Compliance-Audits Hauppauge, NY (http://maps.google.com/maps?q=135+Adams+Avenue+Hauppauge+NY+11788) Quality AssuranceApplyDescriptionAbout CPC:CPC management demonstrates strong ethics while promoting a culture that provides a sense of safety to our team. We empower our colleagues to self-organize, while encouraging a sense of connection and belonging. Management is open to new ideas, promotes organizational learning and nurtures personal growth from within. Recognized by Long Island Press and Dans Papers as a TOP Long Island Workplace, Contract Pharmacal Corp (CPC) is looking for new team members eager to build upon their current skill set. At CPC you are joining an extended family of 1,500 of the industrys top professionals to bring best in class products to market. With over 5,500 dietary supplements, over-the-counter drugs and Rx pharmaceuticals already developed, CPC offers a dynamic and exciting work environment. Position Summary:The Sr. Manager of Quality Assurance Compliance Audits has primary responsibility for all activities related to cGMP audits including hosting regulatory, customer, certification audits and directing/conducting all 3rd party and internal audits. In addition, the position is responsible for managing the Document Control team and facility compliance to support audit functions. Responsibilities:Responsibilities include, but are not limited to: Audit Program: Plan and perform internal & external audits (raw material, printed and non-printed components, contract labs/manufacturers) against GMP regulations, or other appropriate regulations as standards. Oversee the Foreign Supplier Verification Program Establish audit teams with appropriate skill sets Report audit findings Evaluate corrective action plans and monitor completion Ensure audit schedule adherence Issue audit closure letters Schedule, host, and respond to regulatory, customer, and certification audits Coordinate audit documentation and personnelDocument Control: Approve SOPs and other cGMP documentation as needed. Master and Production Batch Record retention Release bulk and finished product to market Facilities: Pest Control Program Environmental Monitoring Program Change Control Approval Equipment IQ/OQ Metrology Food Defense Plan and subject matter expert. Monitor facility metricsSupplier/Contractor Qualification: Conduct Audits Maintain Qualified Supplier list Prepare and/or approve Annual Product reviews (APRs) Prepare and/or approve Customer, Contractor and Supplier Quality AgreementsRequirementsEducation and Experience: Bachelors degree in science, compliance, or related required Masters degree preferred 5+ years of GMP managerial experience within pharmaceutical quality assurance and compliance. Minimum 2 years conducting and hosting GMP audits of pharmaceutical and/or supplement manufacturers. Preferred Certifications:. Foreign Supplier Verification Program .Preventative Controls for Human Food .Preventing Intentional Adulteration of Human Food.ASQ Certified Quality Auditor (CQA) Skills, Abilities and Knowledge: US FDA and EU EMEA cGMPs for pharmaceutical and supplement manufacturing Pharmaceutical Quality Systems ICH, USP, and EP Guidance Analytical principles and manufacturing processes Validation study designs (e.g., method, cleaning, process) Data analysis Effective written and oral communication skills to all employee levels Knowledge of computer program validation principles Excellent technical writing skills and attention to detail Experience in auditing compliance (e.g. EU, FDA, GMPs) Ability to manage multiple tasks and meet deadlines Proficient in Microsoft Word, Excel, Power Point, Microsoft Office Outlook Required training in SOP, cGMP, and General Safety proceduresPhysical Demands: Required to use hands to operate computer controls. Specific vision abilities required include close vision, ability to focus. Work Environment: Required to be present in the office to collaborate with directors, peers and other departments daily. Responsible for adherence to safety policies. Flexible schedule to meet business requirementsSupervisory Responsibilities: Responsible for managing non-union employees

Keywords: Contract Pharmacal Corp, Stamford , Senior Manager; QA Compliance-Audits, Executive , Hauppauge, Connecticut